Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

LIVE – What you will do

Let’s do this.  Let’s change the world.  In this new and vital role, you will develop, implement and maintain coordinated site engagement and operations at key/targeted sites, support global study strategy plan to accelerate development of marketed and early pipeline products.   You’ll also maintain an effective collaborative partnership with all stakeholders, ensuring aligned and synergistic approach to sites’ Amgen experience.

Key Responsibilities:

Leadership of Operational Site Engagement

• Align and lead identification and strategic partnership with key sites to implement a collaborative initiative for clinical trials

• Accountable for strategic long-term operational partnerships with key sites, provide local intelligence

• Proactive and accountable to drive expansion of Amgen’s strategic relationships and meet clinical operational needs

• Primary site-facing, cross-study, operational decision-maker between Amgen and designated key sites to establish Amgen-Institutional operational working practices

• Maintain country expertise, site knowledge to navigate with Amgen and sites with targeted and tailored communication

• Develop, drive and monitor site operational strategies and performance across all therapeutic areas and studies, in strong collaboration with Amgen stakeholders

• Assimilate and report external feedback to evaluate and propose operational process efficiencies, focus and direction for site collaboration on clinical trials

• Orchestrate relationship management and strong internal alignment with Amgen stakeholders (medical, study management, site management, and other key -stakeholders) to drive operational efficiencies

Locally accountable for key, targeted sites execution of clinical studies

• Build and develop strong relationships with key sites to engage with Amgen as choice for clinical trial participation

• Regular communication with key sites to connect on all trials/all stages to determine trends and opportunities and enhance sites’ Amgen experience

• Maintain access to key sites’ leadership & operation teams, point of escalation for potential barriers and operational issues

Global Site Operations Quality Management

• Actively participate in role forums including local/global functional and cross functional initiatives

• Participate in Functional Management Team Meetings as required and applicable country-level project review meetings

WIN – What we expect of you

We are all different, yet we all use our unique contributions to serve patients.  The professional we seek is a hardworking team player with these qualifications and experience:

• Relevant tertiary qualifications

• Experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

• Expertise and in-depth understanding of site engagement with clinical trials, or building and/or coordinating community research networks

• In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines

• Project and Program management including oversight of quality, study deliverables, budgets and timelines

• Fluency in English, both oral and written communication

• Clinical trial management systems and reporting tools and utilization of Key Performance Indicators (KPIs)

• Residency and permission to work in Australia

THRIVE – What you can expect from us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional, personal growth and well-being.

• Vast opportunities to learn and move up and across our global organisation

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising finance and wealth, work/life balance, and career benefits

• Generous Total Rewards Plan—comprising finance and wealth, work/life balance, and career benefits

At Amgen we are committed to doing everything we can to deliver for patients, to keep our staff and their families safe, and to help the communities where we live and work reduce the number of people exposed to COVID-19. As a science-based company, we strongly believe that it is our role to lead the way and therefore it is a requirement that all Amgen Australia employees must be fully vaccinated (certain exemptions will be considered on a case-by-case basis).

Amgen Australia are focused on inspiring talent to directly connect with our brand; today and tomorrow.  We respectfully request agencies do not submit unsolicited resumes and candidates are encouraged to always apply directly.

Applications Close Monday 18th April 2022 , but candidates are encouraged to apply asap.  Preliminary interviews will be virtual and will commence on receipt of application.